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Generex Biotechnology Partner Olaregen Therapeutix Sponsors Annual Meeting of Innovations in Wound Healing

Generex Biotechnology Corporation (OTCQB:GNBT) announced today that Olaregen Therapeutix, a regenerative medicine company contracted to become a subsidiary of Generex, was a co-sponsor of the Annual Meeting of Innovations in Wound Healing (IWH) held December 7 – 9, 2018 in Key West, Florida and attended by over 150 influential clinicians and researchers.

Olaregen also hosted an Advisory Board Meeting attended by esteemed influencers in the specialties of Vascular Surgery, Dermatology, and Wound Healing Science. Robert S. Kirsner, MD, PhD, Chairman & Harvey Blank Professor, Department of Dermatology & Cutaneous Surgery, University of Miami School of Medicine, and Chairman of the IWH chaired Olaregen’s Advisory Board Meeting.

Dr. Kirsner, one of the Principal Investigators for the pivotal trial of Excellagen, and a lead author of the publication, presented findings of the MATRIX Study, published in the peer-reviewed Journal of Wound Repair and Regeneration (Wound Rep Reg (2011)19 302-308). Dr. Kirsner emphasized the “impressive healing rates obtained in the study,” and commented on the “the robust quality of the data” obtained in the MATRIX Study, which is the only randomized clinical trial that has been conducted in both the collagen and flowable markets.

Dr. Oscar Alvarez, Director of Vascular & Wound Center at the University Hospital in Newark, NJ, observed that based on the presentation of the MATRIX data, “Excellagen has shown to accelerate complete healing in diabetic foot ulcers in addition, compared to other Extra Cellular Matrix products (ECMs) and skin substitute devices, Excellagen has the most impressive safety profile.”

Dr. John Lantis, Vice Chairman of Surgery at Mount Sinai, St. Luke’s, and West Hospitals in New York and Dr. William Marston, Professor of Surgery, University of North Carolina concurred that based on the efficacy data and cost effectiveness, they “see a role for Excellagen in the surgical suite.”

Anthony Dolisi, CEO of Olaregen presented a comprehensive review of Excellagen and the company’s vision for the product in each of the indications included in the FDA cleared 510K, as well as a corporate overview detailing Olaregen’s pipeline of regenerative medicine drugs.

The meeting concluded with the advisors committing to a long-term relationship with Olaregen to provide guidance for future development programs and assist in bringing Excellagen to their institutions.

During the IWH meeting Olaregen also met with senior medical executives from Healogics, the largest network of wound care centers in the US, for preliminary discussions on collaboration for an Excellagen clinical trial.

About Olaregen Therapeutics

Olaregen Therapeutix, Inc. is a regenerative medicine company focused on the development, manufacturing and commercialization of products that fill unmet needs in the current wound care market. The company aims to provide advanced healing solutions that substantially improve medical outcomes while lowering the overall cost of care. Olaregen's first product introduction, Excellagen (flowable dermal matrix) is a topically applied product for dermal wounds and other indications. Excellagen is a FDA 510K cleared device for a broad array of dermal wounds, including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/ grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds, enabling Olaregen to market Excellagen in multiple vertical markets. Additionally, Excellagen can serve as an Enabling Delivery Platform for pluripotent stem cells, antimicrobial agents, small molecule drugs, DNA-Based Biologics, conditioned cell media and peptides. Olaregen's initial focus will be in advanced wound care including diabetic foot ulcers (DFU), venous leg ulcers and pressure ulcers. Future products focusing on innovative therapies in bone and joint regeneration comprise the current pipeline. The company's mission is to become a significant force in regenerative medicine and advance the science of healing.

About Generex Biotechnology

Generex is a strategic, diversified healthcare holdings company with offerings in a variety of services, diagnostics, medical devices, and pharmaceutical development. The Company’s direct-to-patient services support its strategy of all-inclusive access to doctors, diagnostics, therapeutics, and additional health-related services to greatly improve the patient experience in receiving care. On the provider side, Generex’s management services remove administrative burdens in multiple provider settings, including private practice and hospital, allowing doctors to devote more time to patient care. Revenue from the Company’s subsidiaries will support clinical advancement of its wholly owned therapeutic products with a focus in immunotherapeutics based on stimulating critical members of the immune response, known as T helper cells, and its proprietary buccal administration of insulin.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

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Last Updated: 13-Dec-2018